In a move that provides clear punctuation to a transition that has been taking place over the past several months, Michael Minogue, president and CEO of heart assist device manufacturer Abiomed (Danvers, Massachusetts), has replaced company founder, Dr. David Lederman, as company chairman.
Lederman, the company said in a statement issued yesterday, has resigned as both chairman and as a board director.
The departure of Lederman seems to underline Abiomed’s apparent de-emphasis of its AbioCor total artificial heart program and increased emphasis on its commercialized, cash-producing products in the heart assist market.
As founder of Abiomed, Lederman created the company more than 20 years ago, the company said in its statement, “to fulfill his dream of developing a totally implantable artificial heart.”
With Lederman’s leadership, Abiomed developed the AbioCor, which the company specifies as “the world’s first, battery-powered, fully implantable replacement heart system,” as well as other systems for short- and long-term support of the heart.
“David’s passion and commitment to patients is a legacy that will continue to inspire Abiomed employees,” Monogue said in the statement. “It is an honor and privilege to follow him as chairman of the company.”
Minogue was named president and CEO of the company in April of last year in a planned succession put in place by Lederman (Medical Device Daily, April 7, 2004).
While Abiomed’s name, over the past several months and years, has been mainly linked to development of the AbioCor artificial heart – a recognition that has brought it a wealth of major media headlines – the company is yet to achieve commercialization of the AbioCor.
The company is one patient-enrollment short of completing the 15-patient trial of the artificial heart – that trial now nearly reaching its fourth year since launched in July of 2001 with the implantation of patient Robert Tools at Jewish Hospital (Louisville, Kentucky).
In the near term is the company’s hoped-for FDA approval of a humanitarian device exemption (HDE) for the AbioCor. It filed the HDE application in September of last year (MDD, Sept. 9, 2004), and the agency’s cardiovascular device panel is set to review the application at a meeting set for June 23.
Since becoming Abiomed’s president, Minogue has put increasing emphasis in various conference presentations on company products other than the AbioCor, repeatedly stating the mantra that the company “wants you to go home with your own heart” rather than an artificial one.
With that theme, he also has emphasized the development of “profit-generating revenue” for the company with the sale of its BVS heart support technology and other heart “recovery products and services,” a message that surely addresses shareholder concerns.
As to the AbioCor, Minogue has noted the heavy R&D costs in developing that product – and a continuing source of R&D spending with the development of a next-generation AbioCor heart – but has emphasized these costs have been a positive rather than a negative.
Earlier this year, he told attendees at the Piper Jaffray Health Care Conference in New York that the AbioCor effort has given the company “a great depth of knowledge” concerning heart assist technology and produced “lots of patents, patents pending and lots of trade secrets” still remaining to be mined (MDD, Jan. 28, 2005).
Abiomed also said in its statement that it has named its employee award and recognition program after Lederman.